1. Study:
A Clinical Study of Intra-cavity Adebrelimab Combined with Best Supportive Care for Pancreatic Cancer Patients with Pleural or Peritoneal Effusion (Malignant Ascites) 2. Why is this study being done? This study is being done to find out if a new approach to treatment is safe and effective for controlling malignant fluid buildup (pleural or peritoneal effusion) in the abdomen or chest in patients with pancreatic cancer. The approach involves putting a drug called Adebrelimab directly into the fluid cavity, in combination with the best available supportive care chosen by your doctor. 3. What is Adebrelimab? Adebrelimab is a type of immunotherapy drug (a PD-L1 inhibitor) that helps the body's immune system fight cancer cells. It is already approved in China for treating some lung cancers. In this study, it is being given directly into the fluid buildup (intra-cavity) to see if it can work better there. 4. What will happen if I join the study?
Screening: First, you will go through tests to see if you are eligible.
Treatment: If eligible, the fluid will be drained. Then, Adebrelimab will be infused into the cavity on Day 1 and Day 8 of each 3-week cycle. You will also receive the best supportive care for your cancer.
Monitoring: You will have regular clinic visits for check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects. 5. How long will I be in the study? Treatment will continue as long as it is controlling the disease, you are not experiencing unacceptable side effects, and you choose to remain in the study. 6. What are the potential benefits? You may experience a reduction in the cancer-related fluid buildup and better control of your cancer. However, benefit cannot be guaranteed. The information from this study may also help other patients in the future. 7. What are the potential risks and side effects? Possible side effects of Adebrelimab include nausea, fatigue, decreased appetite, vomiting, diarrhea, low blood cell counts, and abnormal liver tests. There may also be unknown risks. The best supportive care has its own risks, which your doctor will explain. You will be monitored closely for safety. 8. What are my other choices? You can choose not to participate. This will not affect your standard medical care. Your other options may include drainage of the fluid and other standard treatments aimed at managing your symptoms and cancer. 9. Is participation voluntary? Yes. Your participation is completely voluntary. You can decide to leave the study at any time, for any reason, without any penalty or loss of benefits to which you are entitled.
Age ≥ 18 years.
Asymptomatic effusion not requiring intervention.
Single group
Adebrelimab (PD-L1 inhibitor)
DrugAdebrelimab 600 mg administered by intrapleural or intraperitoneal infusion on Days 1 and 8 of each 3-week cycle (Q3W). Treatment is combined with investigator's choice of best supportive therapy, such as chemotherapy or targeted agents. Administration continues even if effusion decreases or becomes non-drainable.
Overall Survival (OS)
Time from first dose until death from any cause.
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST v1.1.
Progression-Free Survival (PFS)
Time from the date of first dose of study treatment until the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
Disease Control Rate (DCR)
Proportion of patients achieving CR, PR, or stable disease (SD).
Puncture-Free Survival
Time from last dose until the need for re-drainage of effusion or death.
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Sizhen Wang
Lead sponsor
Jinling Hospital, China
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
